BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3425078 · Received October 23, 2013

    Report

    Report Number
    3004209178-2013-19549
    Event Type
    Malfunction
    Date Received
    October 23, 2013
    Report Date
    October 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37602, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387S-40, LOT# V010322, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40, LOT# V010322, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS NOT RECEIVING AS MUCH THERAPEUTIC BENEFIT AS ANTICIPATED. IT WAS ADDED THAT THERE WAS A SHORT BETWEEN 0-3 AND LOWERING C-0 AND C-3. IT WAS INDICATED THAT ALL THE IMPEDANCES WERE NORMAL EXPECTED THE COMBINATION OF 0 AND 3 WHICH WAS 25 OHMS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE. REFER TO MANUFACTURER REPORT # 3004209178-2013-19548.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545086 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00022 YR